MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 14F GLIDELIGHT

Model Number 500-302

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/16/2014

Event Type  Injury  

Event Description

This was a left-sided lead extraction to remove two leads due to bacteremia.The atrial lead (sjm 1688) was removed successfully using a glidelight laser sheath.The glidelight was then used on the dual-coil rv icd lead (sjm riata 1581).The laser sheath with teflon outer sheath was advanced to the right atrium where resistance was met.The laser and outer sheath were pulled back and at this time a drop in blood pressure was noted, an effusion was observed on tee, and a pericardiocentesis was done without improvement after aspiration of clot.A sternotomy was then performed and a patch was placed in the svc.The patient survived the intervention.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 14F GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4238216
• MDR Text Key: 4975264
• Report Number: 1721279-2014-00183
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL UDI: M2045003020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SJM 1688 TENDRIL RA PACING (IMPL UNKNOWN); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SJM 1581 RIATA RV ICD LEAD (IMPL UNKNOWN)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR